With new strategies and drugs available, many different regimens exist for the treatment of HIV. The purpose of this study is to compare three different anti-HIV drug regimens as first-time treatments for HIV infection.

time until treatment-limiting toxicity OR occurrence of Grades 3 or 4 toxicity

Estimated Enrollment:

775

Study Completion Date:

March 2006

Detailed Description:

Numerous treatment options are available to HIV infected patients who are antiretroviral (ARV) therapy naive, but an optimal regimen has not yet been established. This study will compare a nonnucleoside reverse transcriptase inhibitor (NNRTI)-based regimen, a ritonavir (RTV)-enhanced protease inhibitor (PI)-based regimen, and a nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimen for the initial treatment of HIV infection.

Patients will be randomly assigned to one of three study arms. In Arm A, patients will receive lopinavir/ritonavir (LPV/r) twice daily and efavirenz (EFV) once daily before bed. Arm B patients will receive LPV/r twice daily, lamivudine (3TC) once daily, plus either stavudine extended release (d4T XR) once daily, zidovudine (ZDV) twice daily, or tenofovir disoproxil fumarate (TDF) once daily. Patients in Arm C will receive EFV once daily before bed and 3TC plus either d4T XR once daily before bed, ZDV twice daily, or TDF once daily before bed.

Study visits will occur every 4 weeks until Week 24, then every 8 weeks thereafter for a maximum of 96 weeks. Blood will be drawn at every visit and a urine sample will be collected every 8 weeks. Body measurements will be taken at Weeks 24, 48, 72, and 96. Whole body dual-energy x-ray absorptiometry (DEXA) scans will be done at Weeks 48 and 96. Patients must fast before study visits at Weeks 12, 24, 48, 72, and 96. Women in the study will have gynecological assessments every 24 weeks.

Eligibility

Ages Eligible for Study:

13 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria for Step 1:

HIV infected

HIV viral load of 2000 copies/ml or greater within 60 days prior to study entry

Willing to use acceptable means of contraception

d4T XR, TDF, or ZDV chosen as part of an initial regimen prior to randomization to a study arm

Coenrolled in ACTG A5152s

Exclusion Criteria for Step 1:

On ARV therapy for 7 days or more any time prior to study entry

NNRTIs or 3TC at any time prior to study entry

Current peripheral neuropathy of Grade 2 or higher

Pregnancy or breastfeeding

Immunomodulators, vaccines, or investigational therapies within 30 days of study entry. Patients taking a stable or tapering dose of prednisone at less than 10 mg are not excluded.

Human growth hormone within 30 days prior to study entry

Initiation of testosterone or anabolic steroids within 30 days prior to study entry

Certain other medications within 30 days of study entry

Hypersensitivity to components of the study drug formulations

Drug or alcohol use or dependence that would interfere with adherence to study requirements

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050895